Department of Pharmaceuticals proposes to reduce time for regulatory approvals by 50%

The Department of Pharmaceuticals, which comes under the Ministry of Chemicals & Fertilisers, has proposed a draft policy document which aims to reduce the time for regulatory approvals of innovative products by at least 50 per cent, which typically takes about 18-24 months at present.

The department plans to establish a Common Specific Procedure Pathway (CSPP) for each class of product, similar to USFDA. The CSPP will include checklists, prescribed timelines, parallel processing, joint inspections, automatic approvals, and data sharing across regulators.

The document says that all regulators will work together to reduce overlaps and establish timelines for requisite approvals.

It plans to review legislation to enable the regulation of all medical devices in a phased manner with a lead time of 12 months to manufacture for each category of medical device - Class A, B, C & D, and create dedicated licensing provisions for Ayurveda, Siddha & Unani (ASU) drugs.

In addition, the department will come up with a single-window digital portal, which will be hosted by Central Drugs Standard Control Organization (CDSCO), to offer an interface between innovator and regulator. It will also allow automated data transfer across departments and agencies and enable uploading all documents on the integrated portal.

The department claims that the portal would have advanced features like artificial intelligence backed dossier review, deficiency identification using natural language processing (NLP), and automated document management workflows to enhance efficiency and reduce human interface.

The draft policy proposes strengthening the institutional capacity of the CDSCO to provide dedicated support to the industry innovators. This will be done by building in-house expertise in biopharmaceuticals and high-end medical devices.

The draft says that the National Pharmaceutical Pricing Authority (NPPA) will develop expertise in innovative products' pricing while pursuing affordability as an overall objective.

The policy advocates collaboration with relevant international regulatory agencies to enhance the expertise of Indian regulators for approval of new drugs and medical devices and ensure a globally harmonized regulatory system.

The draft proposes a review of the multiple legislations impacting research and development in pharmaceuticals and medical devices to remove inconsistencies and redundancies.